Registration Dossier
Registration Dossier
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EC number: 904-908-6 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 25485-88-5
- EC Number:
- 607-733-0
- IUPAC Name:
- 25485-88-5
- Reference substance name:
- cyclohexyl salicylate
- IUPAC Name:
- cyclohexyl salicylate
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male mice were individually housed and females were housed 4/cage and given free access to rodent diet and drinking water except for 16 hours prior and 3 hours post dosing of the high-dose group and 4-6 prior to 3 hours post dosing of the other test groups. The animal room had a light photoperiod of 12 hours.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Peanut Oil
- Details on exposure:
- 8-week-old CFW-1 (Winkelmann) albino mice (7/sex/group) weighing 20-30 g were gavaged with 3000 mg test substance/kg body weight in peanut oil at a dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.
- Duration of treatment / exposure:
- dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48, or 72 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
300 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1500 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
3000 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 7/sex/group
- Positive control(s):
- Positive control (20 mg/kg body weight of Endoxan)
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- The smears were fixed in methanol, rinsed with distilled water 2x, stained in 10% Giemsa, rinsed with distilled water, and air-dried. The stained smears were examined by light microscopy to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes.
- Evaluation criteria:
- The proportion of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes and the number of micronucleated normochromatic erythrocytes was recorded.
- Statistics:
- Statistical analyses were conducted using the tables of Kastenbaum and Bowman.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.
- Executive summary:
- Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.
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